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Browse Device Recalls

23 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 23 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 23 FDA device recalls.

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DateProductReasonClassFirm
Jan 16, 2026 MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1)... Potential packaging failures, which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Jan 16, 2026 Private Label CVS. Model Number: CVS405406. Helps maintain a moist woun... Potential packaging failures, which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Jan 16, 2026 MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 3180... Potential packaging failures, which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Dec 12, 2025 Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman ... Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi... Class II Integra LifeSciences Corp. (NeuroSciences)
Dec 12, 2025 Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN... Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi... Class II Integra LifeSciences Corp. (NeuroSciences)
Oct 3, 2025 TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Produc... It was determined that when the navigation system is configured with specific revision combinatio... Class II Integra LifeSciences Corp. (NeuroSciences)
Sep 26, 2025 CODMAN Disposable Perforator 9mm. Cranial Perforator. Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 m... Class I Integra LifeSciences Corp. (NeuroSciences)
Sep 26, 2025 CODMAN Disposable Perforator 11mm. Cranial Perforator. Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 m... Class I Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Mod... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet ... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Numb... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Lept... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dres... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number:... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025 Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number... Packaging failures were identified which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
May 23, 2025 MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and fil... Lack of sterility assurance. Class I Integra LifeSciences Corp. (NeuroSciences)
May 22, 2025 Extended Tip Applicator 8CM, Box of 1. Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... Class I Integra LifeSciences Corp. (NeuroSciences)
May 22, 2025 Extended Tip Applicator, 8CM, Box of 5. Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... Class I Integra LifeSciences Corp. (NeuroSciences)
May 22, 2025 Extended Tip Applicator, 15 CM, Box of 5. Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... Class I Integra LifeSciences Corp. (NeuroSciences)
Apr 11, 2025 CODMAN Disposable Perforator, 14mm. Cranial perforator. Inadequate weld that can potentially cause the product to disassemble. Class I Integra LifeSciences Corp. (NeuroSciences)
Apr 11, 2025 CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14... Inadequate weld that can potentially cause the product to disassemble. Class I Integra LifeSciences Corp. (NeuroSciences)
Apr 4, 2025 INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation cath... Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. Class II Integra LifeSciences Corp. (NeuroSciences)

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.